Paseiron Injection (Palonsetron Hydrochloride)

Adult administration

1. Adults 1) Prevention of nausea and vomiting induced by anticancer chemotherapy: Administer palonosetron 0.25 mg intravenously once over at least 30 seconds, 30 minutes before starting chemotherapy. 2) Prevention of postoperative nausea and vomiting: Administer 0.075 mg intravenously once over at least 10 seconds, immediately before induction of anesthesia. As with other antiemetics, routine administration is not recommended in patients expected to have a low likelihood of postoperative nausea and vomiting. Administration of this drug is recommended for patients in whom postoperative nausea and vomiting should be avoided, even if the probability of its occurrence is low. 3) Treatment of postoperative nausea and vomiting: As soon as nausea and vomiting occur, administer 0.075 mg intravenously once over at least 10 seconds. 3. No separate dose adjustment is necessary for elderly patients or patients with hepatic or renal impairment. There are no clinical data in patients with end-stage renal disease undergoing dialysis. This drug must not be mixed with other drugs. Flush the infusion line with normal saline before and after administration of this drug.

Child administration

2 months and older: Prevention of acute nausea and vomiting induced by anticancer chemotherapy: Administer 0.02 mg/kg (up to 1.5 mg) by intravenous infusion once over at least 15 minutes, 30 minutes before starting chemotherapy. Neonates: The safety and efficacy of this drug have not been established (no data are available). Infants (under 24 months): For the prevention of nausea and vomiting induced by anticancer chemotherapy, administer 0.02 mg/kg (up to 1.5 mg) by intravenous infusion once over at least 15 minutes. Data on the use of this drug are limited.

This medication should not be used in patients who have a known allergic reaction to this medication or any of its ingredients. Caution is also required in patients who have shown hypersensitivity to other selective 5-HT3 receptor antagonists, as similar reactions may occur. This medication may slow intestinal transit time and should be used cautiously in patients with a history of constipation or subacute intestinal obstruction, with careful monitoring of the condition. Patients on other serotonergic medications such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) may be at risk for serotonin syndrome and require special observation. This medication is used to prevent nausea and vomiting caused by chemotherapy or after surgery, and side effects may include headache, constipation, diarrhea, dizziness, and fatigue. It may affect the cardiovascular system, and rare occurrences of electrocardiogram abnormalities or arrhythmias may occur, so caution is needed in patients with heart disease. Because this medication can cause dizziness, drowsiness, and fatigue, caution is needed when driving or operating machinery. It should be used during pregnancy only if absolutely necessary, and nursing mothers should carefully consider whether to discontinue breastfeeding due to the potential for the drug to be excreted in breast milk. Safety and efficacy in children and the elderly have not been fully established, so it should be administered carefully based on the judgment of a healthcare professional. In case of overdose, there is no specific antidote, and supportive treatment should be given according to symptoms; dialysis may not be effective. Store by avoiding freezing and keep at room temperature away from light, and always check for discoloration or particulate matter before administration. It is important to take this medication as directed by a physician or pharmacist and to consult immediately in case of any adverse reactions.

Headache, constipation, diarrhea, dizziness, fatigue, abdominal pain, insomnia, non-sustained tachycardia, bradycardia, hypotension, hypertension, myocardial infarction, premature ventricular contractions, sinus tachycardia, sinus arrhythmia, ventricular premature contractions, QT prolongation, allergic dermatitis, rash, motion sickness, tinnitus, burning sensation in the eyes, amblyopia, dyspepsia, dry mouth, hiccups, abdominal distension, weakness, fever, generalized warmth, similar to flu syndrome, increased AST, increased ALT, increased bilirubin, hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, diabetes, decreased appetite, anorexia, arthralgia, drowsiness, hypersomnia, paresthesia, anxiety, euphoria, urinary retention, venous discoloration, venous dilation, neutropenia, pruritus, abnormal movement disorders, pain at the administration site, skin diseases, ECG QT prolongation, bradycardia, hypotension, arrhythmia, ventricular premature contractions, generalized edema, ECG T-wave amplitude reduction, decreased platelet count, hypokalemia, upper abdominal pain, excessive saliva secretion, decreased motility of the small intestine, chills, increased liver enzyme levels, respiratory depression, laryngeal spasm, anemia, dehydration, electrolyte imbalance, cough, wet cough, abdominal bloating, urticaria, shoulder pain, shoulder discomfort, musculoskeletal pain, myalgia, severe pain, bladder dilation, urethral disorder, dysuria, fatigue, chest discomfort, postoperative pain, procedure pain, postoperative anemia, wound discharge, hypersensitivity reaction, injection site reaction, leukopenia, generalized weakness, death, nausea, stomatitis, sputum disease, chest discomfort, chest pain, hepatotoxicity, hemoptysis, armpit pain, tuberculosis, hypercholesterolemia, pelvic pain, excessive skin pigmentation, oral ulcer formation, muscle weakness, acute liver failure, eye inflammation, monocytosis, palpitations, numbness, back pain, increased sweating, tremors, lymphedema, dry cough, epigastric discomfort, neck/shoulder pain, numbness, asthenia, taste disturbances, febrile neutropenia, abdominal discomfort, unspecified seizures, cystitis, dysuria, sores, edema, frequent urination, limb pain, upper respiratory infection, pigmentary abnormalities, palm/sole erythema sensation abnormality, nail changes, postoperative pain, hoarseness, blurred vision, neurotoxicity, neuropathy, renal impairment, nocturia, facial flushing, acne, female perineal pain, dysphagia, flank pain, chills, sore throat, oral opening disorder, oral pain, gingivitis, gum bleeding, decreased red blood cells, generalized edema, mucositis, vaginitis, weight loss, weight gain, pancreatitis, dental damage, hemorrhoids, toothache, nasal cold, nasal congestion, epistaxis, runny nose, hair loss, pain, migraine, pneumonia, dry skin, skin rash, yawning, anal bleeding, anal pain, hematuria, melena, eosinophilia, neutrophilia, dyspnea, erythema, flushing, pleural effusion, acute renal failure, shock, headache, atrioventricular block, heart disease, increased coagulation time, drowsiness, tremor

This medication should be stored at room temperature between 1 to 30 degrees Celsius. It should be kept in a sealed container to prevent air ingress and stored in a dark place to avoid exposure to light.

Appearance

A colorless transparent liquid in a colorless transparent prefilled syringe.

Package unit

1.5mL x 5 prefilled syringes, 5mL x 1 prefilled syringe